Fluid path connectors and container spikes for fluid delivery

ABSTRACT

A fluid connector system features a stopper and an extending section. Installable within an outlet of a fluid container, the stopper defines a passage therethrough. Defining air and fluid conduits, the extending section has a first abutment member threadably connectible thereto and a second abutment member affixed thereto. The extending section is adapted to be extended through the passage of the stopper when assembled thereto. When the first abutment member is tightened about the extending section, the first and second abutment members abut against the exterior and interior sides, respectively, of the stopper. With the stopper installed within the outlet and the extending section and the abutment members therewith assembled to the stopper thereby sealing the passage therein, fluid within the container may be extracted via the fluid conduit as air exterior to the container flows therein via the air conduct to displace the fluid being extracted from the container.

BACKGROUND OF THE INVENTION

The present invention relates to fluid path connectors and containerspikes for fluid delivery and, particularly, to fluid path connectorsand container spikes for delivery of sterile, medical fluids.

The following information is provided to assist the reader to understandthe invention disclosed below and the environment in which it willtypically be used. The terms used herein and objectives described hereinare not intended to be limited to any particular narrow interpretationunless clearly stated otherwise in this document. References set forthherein may facilitate understanding of the present invention or thebackground of the present invention. The disclosure of all referencescited herein are incorporated by reference.

In many medical procedures, such as diagnostic and/or therapeutic drugdelivery, it is desirable to inject a fluid into a patient. For example,numerous types of contrast media (often referred to simply as contrast)are injected into a patient for many diagnostic and therapeutic imagingprocedures. In some medical procedures (for example, computed tomography(CT), angiography, and nuclear magnetic resonance/magnetic resonanceimaging (MRI)) it is desirable to deliver a liquid such as contrastmedium in a timed fashion under relatively high pressures. Suchrelatively high pressures and timed boluses are typically achievedthrough the use of powered injectors.

To, for example, optimize contrast volume delivery, minimize waste ofcontrast and facilitate injector procedures for operators, fluiddelivery systems that are capable of delivering sufficient contrast formultiple injection procedures from a single source of contrast haverecently been developed. Examples of such systems are describedgenerally in U.S. Pat. Nos. 5,569,181, 5,806,519, 5,843,037 and5,885,216, the disclosures of which are incorporated herein byreference. Typically, it is desirable that such fluid delivery systemsinclude a fluid path with a disposable patient interface that ischanged/discarded between each patient to reduce the potential forcross-contamination.

A fluid path connector to connect to a source of fluid is required toincorporate a removable/disposable patient interface in the fluid pathof a fluid delivery or injector system. However, many fluid pathconnectors used in medical procedures exhibit a number of substantialdrawbacks including, for example, difficulty of use and difficulty inmaintaining sterility. Moreover, when such connectors are used at highpressures, leakage and failure also become substantial problems.

Often a piercing member of spike is used to form a fluid connection witha fluid source or container via puncturing of an elastomeric septum orstopper on an outlet of the container. In addition to problemsassociated with, for example, difficulty of use and difficulty inmaintaining sterility, it is often difficult to provided a suitable flowrate for certain medical procedures (for example, delivery of arelatively viscous fluid such as a contrast medium) from spikeconnectors. The spike of such fluid connectors is typically of limitedcross-sectional area to facilitate piercing, resulting in significantlimits upon the size of the fluid line or channel passing through thespike. For example, even the largest fluid line in currently availablespike fluid connectors have a cross-sectional area of approximately 0.08in², significantly limiting the flow rate of fluids therethrough.

It is desirable to develop improved fluid path connectors for fluiddelivery that, for example, reduce or eliminate the above and/or otherproblems associated with currently available fluid path connector andspikes.

SUMMARY OF THE INVENTION

In one aspect, a fluid connector for use with a pierceable containerport is provided. The fluid connector includes an extending sectionincluding a spiked end to pierce the container port. The extendingsection includes at least one air conduit and at least one fluid conduittherethrough. The extending section further includes a first abutmentmember and second abutment member. The first abutment member is adaptedto abut a first or air side of the container port upon piercing of thecontainer port. The second abutment member is spaced from the firstabutment member and is adapted to abut a second or fluid side of thecontainer port. The fluid connector can further include grasping membersextending from the extending section to facilitate rotation (includingtwisting) of the extending section relative to the container port duringpiercing thereof. The fluid connector can also include a check valve influid connection with the air line. In several embodiments, the checkvalve is positioned within the extending section.

In another aspect, a fluid connector system includes a stopper includinga first or air side, a second or fluid side and a passage therethroughfrom the first side to the second side. The fluid connector systemfurther includes a connector including a base having at least one airconduit and at least one fluid conduit therethrough. The base furtherincludes an extending section adapted to extend through the passage. Theextending section includes a first abutment member adapted to abut thefirst side of the stopper and a second abutment member spaced from thefirst abutment member and adapted to abut the second side of the stopperand seal the passage.

In several embodiments, the first abutment member is operativelyconnectible to the base to maintain the second abutment member incompressive contact with the stopper. The first abutment member can, forexample, include threading which cooperates with threading on theextending section of the base.

The second abutment member can, for example, include a wedge-shapedsection, at least a portion of which enters the passage of the stopper.The second abutment member can alternatively include a radially outwardextending flange to abut and apply compressive force to the second sideof the stopper.

The fluid connector system can further include a filter in fluidconnection with the air line. The fluid connector can also include acheck valve in fluid connection with the air conduit on an end of theair conduit interior to the container.

The extending section can also include a cooperating connector adaptedto place a fluid path element in fluid connection with the base. Thecooperating connector can, for example, include a luer connector.

In several embodiments, at least a portion of the connector is sealedwithin the container. The connector can further include a pull tabsection attached to an end of the extending section of the base andextending from the first side of the stopper to enable a user to pullthe extending section of the base through the passage in the stopper sothat the second abutment member abuts the stopper. In severalembodiments, the first abutment member extends radially outward from theextending section of the base and is spaced from the second abutmentmember so that upon pulling a length of the extending section throughthe passage, the first abutment member contacts the first side of thestopper and maintains the second abutment member in compressive andsealing abutment with the stopper. The pull tab section can be removablyattached to the extending section via a cooperating connector on theextending section. The cooperating connector can be adapted to place afluid path element in fluid connection with the base. The cooperatingconnector can, for example, include a luer connector.

In another aspect, a system to connect to an outlet of a containerincludes a cap assembly including an annular cap member connected to apierceable stopper. The cap member includes an opening to provide accessto the pierceable stopper and a connector section removably connectibleto the container. The system can further include a connector memberattachable to the outlet of the container. The connector member includesa cooperating connector section to which the connector section of thecap assembly is removably attachable. The connector section can, forexample, include threading, and the cooperating connector section caninclude cooperating threading. The connector and the cap assembly can,for example, form a removably sealed attachment to seal the outlet ofthe container.

In another aspect, a fluid connector includes a spike to pierce apierceable section of a container and a flexible cover encompassing atleast a portion of the spike. The flexible cover is penetrated by thespike when force is applied to the spike to pierce the pierceablesection of the container.

In several embodiments, the spike includes a fluid line having a minimumcross-sectional area of at least 0.02 in².

The flexible cover can, for example, be formed from a generallycylindrical layer or film of polymeric material which is sealed on anend thereof.

In several embodiments, the flexible cover includes a generally annularelastomeric member to maintain the flexible cover in encompassingconnection with the spike.

In another aspect, a fluid delivery system includes a fluid bagincluding at least one pierceable port and a fluid connector including aspike. A fluid line in the spike has a minimum cross-sectional area ofat least 0.02 in².

In another aspect, a fluid delivery system includes a fluid connectorincluding a fluid line and an vent line therethrough. A source ofpressurized gas is in fluid connection with the vent line.

In a further aspect, a method of connecting a fluid connector to apierceable container port, includes piercing the container port with anextending section including a spiked end. The extending section includesat least one air conduit and at least one fluid conduit therethrough.The extending section also includes a first abutment member and secondabutment member spaced from the first abutment member. The methodfurther includes extending the extending section through the containerport so that the first abutment member abuts a first or air side of thecontainer port and the second abutment member abuts a second or fluidsided of the container port.

In another aspect, a method of forming a fluid connection with acontainer, which includes an outlet, includes placing a stopper inconnection with the outlet, the stopper including a first or air side, asecond or fluid side and a passage therethrough from the first side tothe second side. The method further includes providing a fluid connectorin connection with the stopper. The connector includes a base whichincludes at least one air conduit and at least one fluid conduittherethrough. The base further includes an extending section. Theextending section includes a first abutment member and a second abutmentmember spaced from the first abutment member. The extending sectionextends through the passage such that the first abutment member abutsthe first side and the second abutment member abuts the second side andseals the passage.

In a number of embodiments, the method further includes pulling theextending section of the base through the passage in the stopper so thatthe second abutment member abuts the stopper. The first abutment membercan, for example, extend radially outward from the extending section ofthe base and is spaced from the second abutment member so that uponpulling a length of the extending section through the passage, the firstabutment member contacts the first side of the stopper and maintains thesecond abutment member in compressive and sealing abutment with thestopper.

In a further aspect, a method of providing fluid connection to acontainer, which includes an outlet, includes removably connecting a capassembly to the outlet. The cap assembly includes an annular cap memberconnected to a pierceable stopper. The cap member includes an opening toprovide access to the pierceable stopper and a connector section toremovably connect the cap assembly to the outlet of the container. Themethod can further include attaching a connector member to the outlet ofthe container. The connector member includes a cooperating connectorsection to which the connector section is removably connectible.

In still a further aspect, a method of providing fluid flow from aconnector, which includes a fluid line and an air vent line, includesconnecting a source of pressurized gas to the air vent line topressurize fluid with fluid source in fluid connection with theconnector.

The present invention, along with the attributes and attendantadvantages thereof, will best be appreciated and understood in view ofthe following detailed description taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an embodiment of a spike connector including aflexible and penetrable sterility cover, shield or protector packagedwith a fluid container.

FIG. 1B illustrates the spike connector of FIG. 1A removed from thepackage in alignment to pierce a septum of the fluid container.

FIG. 1C illustrates the spiked connector of FIG. 1A in fluid connectionwith the fluid container.

FIG. 1D illustrates the spiked connector of FIG. 1A in fluid connectionwith a transfer set to deliver fluid to, for example, a pumping devicesuch as a syringe or continuous pumping device.

FIG. 1E illustrates an enlarged view of the spike connector of FIG. 1A.

FIG. 1F illustrates a side view of the spiked connector of FIG. 1A withthe flexible sterility cover removed from connection therewith.

FIG. 1H illustrates another side view of the flexible sterility cover,rotated approximately 90° about its axis from the view of FIG. 1F.

FIG. 1G illustrates another enlarged view of the spiked connector ofFIG. 1A.

FIG. 2A illustrates an embodiment of a system or kit including atransfer set, which includes a spike connector having a flexible andpenetrable sterility shield or protector, packaged with a fluidcontainer.

FIG. 2B illustrates the system of FIG. 2A removed from the package withthe spiked connector in alignment to pierce a septum of the fluidcontainer.

FIG. 2C illustrates the spiked connector and transfer set of FIG. 2A influid connection with the container, wherein the container is invertedto, for example, deliver fluid to a pumping device such as a syringe orcontinuous pumping device.

FIG. 2D illustrates an enlarged view of the transfer set of FIG. 2A.

FIG. 3A illustrates an embodiment of a spike connector of the presentinvention including a spike having a fluid line of enlargedcross-sectional area, wherein the spike connector is in a disassembledor exploded state.

FIG. 3B illustrates the spike connector of FIG. 3A in an assembledstate.

FIG. 3C illustrates the spike connector of FIG. 3A used in connectionwith a flexible and penetrable sterility cover, shield or protector.

FIG. 3D illustrates the spike connector of FIG. 3A in alignment topenetrate a fluid container (fluid bag) and after connection with thefluid bag.

FIG. 4A illustrates a container including a standard elastomeric stoppertherein and two embodiments of replacement stoppers adjacent to thecontainer.

FIG. 4B illustrates an embodiment of a connector of the presentinvention including a sealing connector assembly which passes through apassage in an elastomeric stopper.

FIG. 4C illustrates the connector of FIG. 4B in fluid connection with acontainer.

FIG. 4D illustrates a fluid connector similar to that of FIG. 4A whereinthe connector includes an exterior retainer to retain the stopper insealing engagement with the container.

FIG. 5A illustrates another embodiment of a fluid connector of thepresent invention in a partially disassembled state.

FIG. 5B illustrates a partially transparent view of the fluid connectorof FIG. 5A in an assembled or connected state.

FIG. 5C illustrates a partially transparent view of the fluid connectorof FIG. 5A in operative connection with a compressible stopper.

FIG. 5D illustrates another view of the fluid connector of FIG. 5A inoperative connection with the compressible stopper.

FIG. 5E illustrates operation of the fluid connector of FIG. 5A to forma seal with an compress the compressible stopper.

FIG. 5F illustrates the fluid connector of FIG. 5A in operativeconnection with a fluid container.

FIG. 6A illustrates an embodiment of a fluid connector of the presentinvention wherein the fluid connector is positioned within a containerin a non-deployed or storage state.

FIG. 6B illustrates initial unsealing and deployment of the fluidconnector of FIG. 6A.

FIG. 6C illustrates full deployment of the fluid connector of FIG. 6A.

FIG. 6D illustrates an enlarged disassembled or exploded view of thefluid connector of FIG. 6A.

FIG. 7A illustrates a perspective view of an embodiment of a fluidconnector of the present invention.

FIG. 7B illustrates a side view of the fluid connector of FIG. 7A.

FIG. 7C illustrates a rear or top view of the fluid connector of FIG.7A.

FIG. 7D illustrates a forward or bottom view of the fluid connector ofFIG. 7A.

FIG. 7E illustrates the fluid connector of FIG. 7A in fluid connectionwith a septum of stopper of a container.

FIG. 7F illustrates a side, cross-sectional view of the fluid connectorof FIG. 7A.

FIG. 7G illustrates another side, cross-sectional view of the fluidconnector of FIG. 7A.

FIG. 7H illustrates a perspective, partially cutaway view of the fluidconnector of FIG. 7A.

FIG. 7I illustrated another perspective view of the fluid connector ofFIG. 7A.

FIG. 7J illustrates another side view of the fluid connector of FIG. 7A.

FIG. 7K illustrates another side view of the fluid connector of FIG. 7A.

FIG. 8A illustrates an embodiment of a system including a fluidconnector and a source of pressurized gas in connection with the airline or vent of the fluid connector.

FIG. 8B illustrates an embodiment of a system including a fluidconnector and an gas/air compressor in connection with the air line orvent of the fluid connector.

FIG. 8C illustrates an embodiment of a system including a fluidconnector and a compressed gas cartridge in connection with the air lineor vent of the fluid connector.

FIG. 9A illustrates a side disassembled or exploded view of anembodiment of a system of the present invention including a combinationcontainer cap and stopper wherein an operator can either spike thestopper using a spiked connector or remove the cap to, for example, fillthe syringe with a quick fill tube.

FIG. 9B illustrates a side view of the system of FIG. 9A whereinthreading of the system has been placed in connection with a standardcontainer.

FIG. 9C illustrates a side view of the system of FIG. 9A wherein the capand stopper assembly has been placed in operative connection with thethreading on the container.

FIG. 9D illustrates a top view of the system of FIG. 9A wherein the capand stopper assembly is in operative connection with the container and aprotective covering has been removed.

DETAILED DESCRIPTION OF THE INVENTION

As used herein and in the appended claims, the singular forms “a,” “an”,and “the” include plural references unless the content clearly dictatesotherwise. Thus, for example, reference to “a filter” includes aplurality of such filters and equivalents thereof known to those skilledin the art, and so forth, and reference to “the filter” is a referenceto one or more such filters and equivalents thereof known to thoseskilled in the art, and so forth.

FIGS. 1A through 1H illustrate an embodiment of a sterility cover,protector or shield 100 for use in connection with a fluid connector 200(or spike connector). Fluid connector 200 includes a piercing spike 210to pierce a septum or elastomeric stopper 310 of a fluid container orbottle 300 to place a fluid line or channel passing through spike 210 offluid connector in fluid connection with container 200. Fluid connector200 also includes a check ball and air filter 220 in fluid connectionwith an air line or vent line passing through spike 210. As used herein,the term “spike” refers generally to an extending section which tapersover at least a portion thereof to a generally pointed end suitable forpiercing.

Fluid connector 200 further includes a swabable valve 230 to, forexample, connect to a transfer set 400 as illustrated in FIG. 1D.Suitable swabable valves are, for example, disclosed in U.S. Pat. No.6,651,956 and are commercially available from Halkey-Roberts Corporationof Saint Petersburg, Fla. External surfaces in the proximity of a valvestem of swabable valve 230 are accessible to be wiped with a sterileswab. Valve 230 can, for example, connect to a first luer-type connector410 on a first end of a transfer set 400, which can further includeflexible tubing 420 and a second luer-type connector 430 on a second endthereof. Second luer-type connector 430 can, for example, be connectedto a pressurizing device 500 such as a syringe in operative connectionwith a powered injector (for example, a STELLANT injector available fromMedrad, Inc. of Indianola, Pa.) or a continuous pump as, for example,described in U.S. Pat. Nos. 5,916,197 and 6,197,000 and illustrated inFIG. 1D (not to scale).

In the embodiment illustrated in FIGS. 1A through 1H, flexible,protective covering or shield 100 is provided over spike 210. Cover 100includes a first, closed end 110 that is pierceable, tearable orbreakable by spike 210. First end 110 can, for example, be formed of apierceable, tearable or breakable material such as apolymeric/elastomeric material or a paper material. A body or sidesection 112 can, for example, be formed from a flexible or collapsiblematerial such as a polymeric film or a paper, which is connected to orformed integrally with first end 110. As illustrated in FIG. 1H, in oneembodiment, body section was formed to be generally cylindrical and theforward end thereof (that is, the end proximate the tip of spike 210)was closed or sealed (for example, via heat sealing, adhesive etc.) tocreate closed, first end 112. Cover 100 further includes a second end orbase 120. In several embodiments, second end 120 included a generallyannular elastomeric member that attaches to spike 210 via compressivepressure applied by the elastomeric member. Cover 100 can, for example,be attached to or placed in connection with spike 210 in many differentmanners to retain cover 100 in connection with spike 210 (for example,via an adhesive).

In the embodiment of FIGS. 1A through 1G, cover 100 is generally in theform of a closed sleeve having a diameter or cross-sectional areal onlyslightly larger than that of spike 210. Forming cover 100 as arelatively close-fitting sleeve assists in ensuring that cover 100 doesnot interfere with the normal operation of connector 200.

Protective cover 100 can be sterilized and distributed in operativeconnection with sterilized connector 200 in sterile packaging 600 (seeFIG. 1A), which can, for example, also include sterilized container 300.Protective cover 100 assists in maintaining the sterility of spike 210,for example, after removal from package 600 and during piercing of/fluidconnection with septum or stopper 310.

As illustrated in FIG. 1B, after connector 200 is removed from packaging600, spike 210 is aligned with septum 300 and contacted therewith.Application of force to connector 200 in a direction toward container300 will cause spike 210 to pierce or otherwise open first end 110 ofcover 100 and then pierce septum 310. As spike 210 is forced throughseptum 310 and into container 300, flexible body section 112 folds orcollapses into a collapsed state as illustrated in FIGS. 1C and 1D.During the insertion process, however, protective cover 100 maintainsthe sterility of spike 210. As a further precaution, a sterilizing swabcan, for example, be applied to at least second end 120 of protectivecover 100 prior to contact with septum 310 if there is concern thatprotective cover 100 has contacted a non-sterile surface after removalfrom packaging 600.

FIGS. 2A through 2D illustrate another embodiment of a fluid deliverysystem including container 300, a transfer set 400 a and a fluidconnector 200 a. In the embodiment illustrated in FIGS. 2A through 2D,fluid connector 200 a is permanently connected to or formed as anintegral component of transfer set 400 a. In other respects, the fluiddelivery system of FIGS. 2A through 2D is similar to that of FIGS. 1Athrough 1G and elements of the fluid delivery system of FIGS. 2A through2D are numbered similarly to corresponding elements of the fluiddelivery system of FIGS. 1A through 1G with the addition of thedesignation “a” thereto. As illustrated in FIG. 2A, container 300, atransfer set 400 a and a fluid connector 200 a can be packaged togetherin sterile packaging 600 a. In the illustrated embodiment, a band 450 isplaced around coiled tubing 420 a of transfer set 400 a and tubing 420 ais placed around the top of container 300 in packaging 600 a.

FIGS. 3A through 3D illustrates another embodiment of a fluid connector700 including a spike 710. Spike 710 includes at least one fluid flowline, conduit or channel therethrough that has a larger diameter orcross-sectional area larger than found in currently available spikedfluid connectors. In several embodiments, spike 710 was a cannula formedfrom a relatively stiff material (for example, a metal, a polymericmaterial or other material) to facilitate a relatively thin wall and arelatively large fluid channel therein. Forming spike or cannula 710from a metal can, for example, provide for suitable stiffness and arelatively thin wall to allow piercing of a container septum (forexample, a septum of a port 310′ of a fluid bag 300′ as illustrated inFIG. 3D) with large diameter spike 710. In the illustrated embodiment, aconnector base 720 is in fluid connection with a male luer-type or luerconnector 730 at a first end thereof. Connector base 720 is in fluidconnection with spike 710 at a second end thereof. In the illustratedembodiment, a cylindrical or tubular section 740 (for example, a silicontube section) encompasses spike 710 and acts as a guide in placingconnector 700 in operative, fluid connection with port 310′ asillustrated in FIG. 3D. As illustrated in FIG. 3C, protective cover 100can be used in connection with fluid connector 700.

As described in connection with spike 710, a number of fluid connectorsof the present invention include at least one fluid flow line, conduitor channel therethrough that has a larger diameter or largercross-sectional area than found in currently available spiked fluidconnectors (for example, greater than 0.008 in²). In severalembodiments, the fluid line of the fluid connectors of the presentinvention has a minimum cross-sectional area of at least 0.010 in², atleast 0.016 in², at least 0.020 in², or at least 0.030 in². Therelatively large fluid line or lines can sustain flow rates of, forexample, 30 mls/sec or higher using, for example, a heated (toapproximately, 98.6° C.) contrast fluid having a viscosity in the rangeof approximately 10-12 centipoise. For example, one fluid connector ofthe present invention (that is, connector 1000 of FIGS. 7A through 7K)had a fluid line having a minimum cross-sectional area (the area in thevicinity of the fluid inlet ports) of approximately 0.038 in². Asustained flow rate of greater than 30 ml/sec with a heated contrastfluid having a viscosity in the range of approximately 10-12 centipoisewas achieved. A sustained flow rate of greater than 50 ml/sec with thatfluid connector with water (having a viscosity of approximately 1centipoise) was achieved. These flow rates were achieved in drawing thefluid from a container such as bottle container 300 or bag container300′ under atmospheric pressure using three-valve continuous flow pump500 (see FIG. 1D) as disclosed in U.S. Pat. Nos. 5,916,197 and6,197,000, which was operated under power of a motor 510.

FIGS. 4A through 4D illustrate another embodiment of a fluid deliverysystem for delivery of a fluid from a container 300. In the illustratedembodiment, container 300 includes a stopper 310 in the outlet thereofas described above. A fluid connector 800 includes a replacement stopper810 including a passage or conduit 812 therethrough. FIG. 4A alsoillustrates an alternative stopper 810′ including a passage 812′ thegenerally conforms to the shape of a second abutment member 826 of fluidconnector 800 discussed below. A base 820 of connector 800 can, forexample, include a fluid flow line, conduit or channel (not shown)therethrough of relatively large cross-sectional area to accommodaterelatively high flow rates. To place connector 800 in fluid connectionwith container 300, stopper 310 is removed from container 300 andreplaced with fluid connector 800, including stopper 810.

In assembling connector 800, an extending section 822 of base 820 ispassed through passage 812 in stopper 810 until a first abutment memberin the form of a threaded compression sleeve 830 can form a threadedconnection with threading 824 on base 820. Connector 800 can then beplaced in fluid connection with container 300 via stopper 810 with firstabutment member 830 on a first or fluid side of stopper 810 and secondabutment member 826 on a second or fluid side of stopper 810.

In that regard, base 820 includes a wedge-shaped, lower or secondabutment member 826. The radius of base 810 increases over the length ofsecond abutment member 826. Rotation of threaded first abutment member830 relative to base 820 draws second abutment member 826 within passage812, sealing passage 812. The drawing of second abutment member 826within passage 812 also causes compression of stopper 810 (which can,for example, be formed from a silicone rubber) against the innerdiameter of the outlet of container 300, thereby improving the sealedconnection therewith and creating a generally leakproof seal.

Compression of stopper 810 by second abutment member 826 assists inretaining stopper 810 in sealing engagement with container 300 when, forexample, container is inverted to deliver fluid. In an alternativeembodiment illustrated in FIG. 4D, a retainer or retaining cap 870(including an opening 872 through which an upper potion of fluidconnector 800 can pass) forms, for example, a snap fit with container300 to assist in retaining stopper 810 in sealing engagement withcontainer 300, even when inverted. In the embodiment of FIG. 4D, asecond abutment member 830′ need only form a sealing engagement withstopper 810 (sealing passage 812) and need not (but may) compressstopper 810.

An air filter 840 is in fluid connection with an air line (not shown) inthe vicinity of and air side end of extending section 822. An air checkvalve 850 is in fluid connection with the air line at an opposite end828 (that is, the fluid side end) of the air or vent line. Inclusion ofcheck valve 850 in air filter line reduces or eliminates the chances ofliquid entering and clogging filter 840, which can result indeterioration of the operation of connector 800. The inclusion of checkvalve 850 can, for example, be beneficial if reuse of connector 800 isdesired.

A connector 860 such as a luer-type connector is placed in fluidconnection with the fluid line extending through base 820 at the end ofextending section 822. Connector 860 can, for example, be placed influid connection with a transfer set such as transfer set 400 describedabove.

Use of connector 800, including replacement stopper 810, facilitates theincorporation of relatively large fluid conduits within the connector.Such large (inner diameter) fluid conduits enable one to achieverelatively high flow rates as compared to currently available spikedfluid connectors.

FIGS. 5A through 5F illustrate another embodiment of a fluid deliverysystem for delivery of a fluid from container 300, which is similar indesign and operation to the fluid delivery system of FIGS. 4A through4C. Elements of the fluid delivery system of FIGS. 5A through 5F arenumbered similarly to corresponding elements of the fluid deliverysystem of FIGS. 4A through 4C with the addition of the designation “a”thereto.

Fluid connector 800 a includes a replacement stopper 810 a including apassage or conduit 812 a therethrough. A base 820 a of connector 800 acan, for example, include a relatively large inner diameter passage,conduit or fluid line 821 a therethrough. To place connector 800 a influid connection with container 300, stopper 310 is removed fromcontainer 300 and replaced with fluid connector 800 a, including stopper810 a.

In assembling connector 800 a, an extending section 822 a of base 820 ais passed through passage 812 a in stopper 810 a until a threaded firstabutment member 830 a (which can include radially extending flanges orfins 832 a to facilitate grasping) can form a threaded connection withthreading 824 a on base 820 a. Connector 800 a can then be placed influid connection with container 300 via stopper 810 a.

Base 820 a includes a second abutment member including a flange 826 awhich extends generally perpendicular to the longitudinal axis of base820 a. As, for example, illustrated in FIGS. 5D and 5E, rotation offirst abutment member 830 a (which abuts a first or air side of stopper810) relative to base 820 a draws second abutment member into sealingcontact with stopper 810 a, further causing compression of stopper 810 a(which can, for example, be formed from a silicone rubber) and forcingstopper 810 a against the inner diameter of the outlet of container 300,thereby improving the seal therewith and creating a generally leakproofseal.

An air filter 840 a is in fluid connection with an air line 827 a formedin base 820 a in the vicinity of an end of extending section 822 a. Anair check valve 850 a is in fluid connection with air line 827 a at anopposite end 828 a of base 820 a. As described above, inclusion of checkvalve 850 a in air filter line 827 a reduces or eliminates the chancesof liquid entering and clogging filter 840 a.

A connector 860 a such as a luer-type connector or a swabable valve canbe placed in fluid connection with fluid line 821 a extending throughbase 820 a at the end of extending section 822 a. Connector 860 a can,for example, be placed in fluid connection with a transfer set such astransfer set 400 described above.

FIGS. 6A through 6D illustrate another embodiment of a fluid deliverysystem or fluid connector for delivery of a fluid from a container suchas container 300. Similar to the fluid delivery systems or connectors ofFIGS. 4A through 5F, fluid connector 900 includes a stopper 910including a passage or conduit 912 therethrough. A base 920 of connector900 can, for example, include a relatively large inner diameter passage,conduit of fluid line (not shown) therethrough. To place connector 900in fluid connection with container 300, for example, stopper 310 can beremoved from container 300 and replaced with fluid connector 900,including stopper 910. However, connector 900 is preferably used as theoriginal stopper in connection with container 300 upon filling thereofwith fluid, obviating the need for replacing stopper 310.

In assembling connector 900, a pull tab section 970, which can extendthrough passage 912 in stopper 910, is connected to an end of anextending section 922 of base 920. For example, pull tab section 970 caninclude a connector 972 (for example, a male luer connector) andextending section 922 can include a cooperating connector 960 on an endthereof (for example, a female luer connector). Extending section 922includes a first abutment member 925. Base 920 further includes a secondabutment member or wedge 926 which operates similarly to compressionsection 826 described above. In general, the radius of base 920increases over the length of compression section 926 to generally form awedge.

In deployment or activation of connector 900, one first removes anoptional sterile cover 905. The user can then grasp a pull tab 974 ofpull tab section 970 and pulls extending section 922 of base 920 throughpassage 912 in stopper 910. Second abutment member 926 is thereby drawnwithin passage 912, sealing passage 912 and causing compression ofstopper 910 (which can, for example, be formed from a silicone rubber)against the inner diameter of the outlet of container 300, therebyimproving the seal therewith and creating a generally leakproof seal.Base 920 is drawn upward (in the orientation of FIGS. 6A through 6C)until first abutment member 925 is drawn through passage 912 and a lower(once again, in the orientation of FIGS. 6A through 6C) surface of firstabutment member 925 abuts an upper surface of stopper 910, therebylocking base 920 in the deployed or active position illustrated in FIG.6A. At this point, pull tab section 970 can be removed and a fluid linesuch as transfer set 400 can be attached to fluid connector 900 viaconnector 960.

An air filter 940 is in fluid connection with an air line (not shown)formed in base 920 and is positioned on base 920 in the vicinity of anend of extending section 922. An air check valve 950 is in fluidconnection with the air line at an opposite end 928 of the air line. Asdescribed above, inclusion of check valve 950 in the air filter linereduces or eliminates the chances of liquid entering and clogging filter940. During storage of fluid connector 900 within container 300, aremovable, protective covering 942 can be placed over air filter 940 oran inlet thereto. Protective covering 942 can, for example, be formedfrom a polymeric film with an adhesive on one side there of to adhere tobase 920 and prevents fluid from entering air filter 940 when fluidconnector 900 is stored within container 300. When fluid connector 900is deployed (as illustrated in FIG. 6C), protective covering 942 isremoved to allow air to enter container 300 during flow therefrom.

FIGS. 7A through 7K illustrate another embodiment of a fluid connector1000 including an extending section 1022 in the form of a tapered orpointed spike to pierce stopper 310 of container 300. Extending sectionor spike 1022 includes a fluid line 1021 (see, for example, FIG. 7F)therethrough of relatively large cross-sectional area as described aboveto provide increased flow rates as compared to currently available spikeconnectors. Fluid line 1021 includes at least one inlet 1021 a (two inthe illustrated embodiment) via which fluid from a container such ascontainer 300 enters the fluid line and an outlet 1060, which can beformed as or can connect to a connector (for example, a luer connector)as described above. Extending section 1022 further includes an air orvent line 1027 (see, for example, FIG. 7F) therethrough including atleast one outlet 1027 a. Alternatively, a check valve 1050 can beincorporated into filter 1040 or extending section 1022. A check valve1050, which is incorporated into extending section 1022, is in fluidconnection with air line 1027. An air filter 1040 is in fluid connectionwith an inlet 1027 b of air line 1027 (see, for example, FIGS. 7C and7F).

In the illustrated embodiment, fluid line 1021 was of a generallycircular cross-sectional shape. Just downstream (that is, toward outlet1060) from the centerline of fluid line inlets 1021 a, extending sectionhad an outer diameter of approximately 0.327 in. The wall thickness wasapproximately 0.30 in, resulting in an inner diameter D₁ ofapproximately 0.267 in (see FIGS. 7G and 7H). The cross-sectional area(that is, a minimal cross-sectional area) of fluid line 1021 at thatpoint was calculated to be approximately 0.038 in². The inner diameterof fluid line increased to a maximum inner diameter D₂ of approximately0.375 in (see FIG. 7G) over the length of extending section 1022,corresponding to a calculated maximum cross-sectional area ofapproximately 0.063 in². The wall thickness remained generally constantat approximately 0.030 in. As described above, a sustained flow rate ofgreater than 30 ml/sec for a heated contrast fluid and a sustained flowrate of greater than 50 ml/sec for water were achieved through fluidconnector 1000 in drawing the fluid from a container under atmosphericpressure using three-valve continuous flow pump 500.

Connectors 1000 used in the above-described studies were formed from anepoxy resin in a stereolithography or SLA system. In general, connectorsof the present invention can be made from a variety of materialincluding, but not limited to, metals and/or polymeric materials.Suitable polymeric materials for connectors of the present inventioninclude, but are not limited to, acrylonitrile butadiene styrene (ABS)and polyvinyl chloride (PVC).

Extending section 1022 includes a first abutment member 1030 to abut afirst or air side of stopper 310 and a second abutment member 1025spaced from first abutment member 1030 to abut a second of fluid side ofa pierceable septum of stopper 310 to retain fluid connector 1000 influid connection with stopper 310 and container 300. In that regard,enlargement of extending section 1022 (as compared to currentlyavailable fluid connector spikes) results is substantial force exertedby elastomeric stopper 300 upon extending section 1022 tending to pushfluid connector out of connection with stopper 300. The entrapment of aportion of stopper 310 between first abutment member 1030 and secondabutment member 1025 prevents disengagement. To facilitate fullconnection of fluid connector 1000 with stopper 310, wherein thepierceable portion of stopper 310 is engages on the first side thereofby first abutment member 1030 and on the second side thereof by secondabutment member 1025, fluid connector 1000 includes extending flanges1032 to facilitate rotation or twisting of fluid connector 1000 duringpenetration of stopper 310. An air side end 1060 of fluid connector 1000can include a connector such as luer connector as described above to,for example, attach transfer set 400. A filter (not shown) as describedabove can also be placed in fluid connection with the air side end ofthe air line.

FIG. 8A illustrates the use of a source or reservoir 1100 of lowpressure (but higher than atmospheric pressure) gas (for example,sterile air) in fluid connection with an air vent 1210 of a fluidconnector 1200 to increase the flow rate of fluid through the fluid line(not shown) of fluid connector 1200 when fluid connector is in fluidconnection with a container such as container 300. Source 1100 can, forexample, include a refill port 1110.

FIG. 8B illustrates a source of pressurized gas (for example, air)including a compressor 1100 a in fluid connection with air vent 1210 offluid connector 1200 to increase the flow rate of fluid through thefluid line of fluid connector 1200.

FIG. 8C illustrates a source of pressurized gas (for example, air orsterile air) including a cartridge 1100 b in fluid connection with airvent 1210 (not shown in FIG. 8C) of fluid connector 1200 to increase theflow rate of fluid through the fluid line of fluid connector 1200.Sources of pressurized gas such as described in connection with FIGS. 8Athrough 8C can be used in connection with virtually any fluid connectorincluding an air vent line to increase fluid flow through the fluid lineof the fluid connector.

FIGS. 9A through 9D illustrate a system for converting a container suchas bottle 300 to a container that can either be spiked using a spikedfluid connector (as, for example, illustrated in FIGS. 1A through 3C and7A through 7D) or the cap can be removed to enable access to the fluidwithin bottle 300 via, for example, a quick fill tube to, for example,fill a syringe. In the illustrated embodiment, system 1300 includes agenerally cylindrical or annular cap member 1310 (formed, for example,from a polymeric material) which forms a connection (for example, via afriction fit, snap fit and/or an adhesive or other bond) with a stoppermember 1320. System 1300 also includes a generally cylindrical orannular connector member 1330 (formed, for example, from a polymericmaterial) which includes a connection section such as a threadingsection that connects to the outlet section of container 300 (forexample, via an overforming process or an adhesive or other bondingprocess) as illustrated in FIG. 7B. An inner wall of cap member 1310includes cooperating connecting section such as a cooperating threadingsection so that cap assembly 1340 (including cap member 1310 andattached stopper member 1320) is removably and sealingly attachable toconnector member 1330, which is attached to container 300. System 1300can also include a protective covering 1350 (for example, a polymericfilm) to, for example, assist in maintaining sterility and to provide anindication of tampering. A pull tab 1352 can be provided to assistremoval of covering 1350. When cap assembly 1340 is attached tocontainer 300, and covering 1350 is removed, an upper surface of stoppermember 1320 is accessible via an opening 1312 (see FIG. 7D) in an upperend of cap member 1310. As described above, cap assembly 1340 can beremoved from connection with container 300 by twisting cap assembly 1340to disengage cap member 1310 from connection with connector member 1330.

In many currently available containers for pharmaceuticals (such ascontrast media) which include a pierceable stopper, a user can remove ametal tab from the container to remove the pierceable stopper, enablingpouring of fluid from the container or use of a fill tube (to, forexample, fill a syringe). However, removal of metal tabs on currentlyavailable containers can cause a safety hazard as a result of remainingsharp metal edges. These edges can easily cut or pierce surgical gloves.In the case system 1300, in which stopper 1320 is attached to removablecap 1310, the stopper can be removed without worry of creating sharpmetal edges. Further, if removal of cap assembly 1340 is not desirable,a user can spike stopper 1320 in the usual manner.

The foregoing description and accompanying drawings set forth thepreferred embodiments of the invention at the present time. Variousmodifications, additions and alternative designs will, of course, becomeapparent to those skilled in the art in light of the foregoing teachingswithout departing from the scope of the invention. The scope of theinvention is indicated by the following claims rather than by theforegoing description. All changes and variations that fall within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

1. A fluid connector system for use with a fluid container, the fluidconnector system comprising: (a) a stopper configured to be installedwithin an outlet of the fluid container, the stopper including anexterior or air side and an interior or fluid side and defining apassage therethrough; (b) a connector including a base that defines atleast one air conduit and at least one fluid conduit therethrough, thebase further including an extending section adapted to be extendedthrough the passage, the extending section including a first abutmentmember and a second abutment member spaced from the first abutmentmember; and (c) a pull tab section removably connected to an end of theextending section, the pull tab section for enabling the extendingsection and the first and the second abutment members therewith to beextended from (I) a storage state wherein a pull tab of the pull tabsection is located approximate the exterior side of the stopper and thefirst and the second abutment members are located on the interior sideof the stopper into (II) a deployed state wherein the pull tab sectionis located away from the exterior side of the stopper and the first andthe second abutment members abut the exterior and interior sides,respectively, of the stopper and thereby seal the passage therein; suchthat with the stopper installed within the outlet of the fluid containerand the first and the second abutment members set in the deployed statefluid within the fluid container may be extracted therefrom via the atleast one fluid conduit as air exterior to the fluid container flowstherein via the at least one air conduct to displace the fluid beingextracted from the fluid container.
 2. The fluid connector system ofclaim 1 further comprising a sterile cover configured to cover theoutlet of the fluid container, the exterior side of the stopper and thepull tab approximate thereto when in the storage state.
 3. The fluidconnector system of claim 1 wherein the second abutment member comprisesa wedge-shaped section and is adapted to enter the passage of thestopper when extended into the deployed state.
 4. The fluid connectorsystem of claim 1 further comprising a filter in fluid connection withthe at least one air conduit.
 5. The fluid connector system of claim 4further comprising a check valve in fluid connection with the at leastone air conduit interior to the fluid container.
 6. The fluid connectorsystem of claim 1 wherein the first abutment member extends radiallyoutward from the extending section of the base such that when extendedinto the deployed state the first abutment member by a surface thereofcontacts the exterior side of the stopper so as to maintain the secondabutment member in compressive and sealing abutment against the interiorside of the stopper.
 7. The fluid connector system of claim 1 whereinthe pull tab section is removably connected to the end of the extendingsection via a cooperating connector on the extending section, thecooperating connector being adapted to place a fluid path element influid connection with the at least one fluid conduit within the basewhen the extended section is extended into the deployed state.
 8. Thefluid connector system of claim 7 wherein the cooperating connectorcomprises a luer connector.
 9. The fluid connector system of claim 1wherein the at least one fluid conduit includes a cooperating connectorat the end thereof, the cooperating connector being adapted to place afluid path element in fluid connection with the at least one fluidconduit when the extended section is extended into the deployed state.10. The fluid connector system of claim 9 wherein the cooperatingconnector comprises a luer connector.
 11. A fluid connector system foruse with a fluid container, the fluid connector system comprising: (a) astopper configured to be installed within an outlet of the fluidcontainer, the stopper including an exterior or air side and an interioror fluid side and defining a passage therethrough; and (b) an extendingsection that defines at least one air conduit and at least one fluidconduit therethrough, the extending section having a first abutmentmember threadably connectible thereto and a second abutment memberaffixed thereto, the extending section adapted to be extended throughthe passage of the stopper when assembled thereto such that the firstabutment member abuts against the exterior side of the stopper and thesecond abutment member abuts against the interior side of the stopperwhen the first abutment member is tightened about the extending section;wherein with the stopper installed within the outlet of the fluidcontainer fluid and the extending section and the first and the secondabutment members therewith assembled to the stopper thereby sealing thepassage therein fluid within the fluid container may be extractedtherefrom via the at least one fluid conduit as air exterior to thefluid container flows therein via the at least one air conduct todisplace the fluid being extracted from the fluid container.
 12. Thefluid connector system of claim 11 wherein the at least one fluidconduit includes a cooperating connector at the end thereof, thecooperating connector being adapted to place a fluid path element influid connection with the at least one fluid conduit.
 13. The fluidconnector system of claim 12 wherein the cooperating connector comprisesa luer connector.
 14. The fluid connector system of claim 11 furthercomprising a filter in fluid connection with the at least one airconduit.
 15. The fluid connector system of claim 14 further comprising acheck valve in fluid connection with the at least one air conduitinterior to the fluid container.
 16. The fluid connector system of claim11 wherein the second abutment member comprises a wedge-shaped sectionand is adapter to enter the passage of the stopper when the firstabutment member is tightened about the extending section.
 17. The fluidconnector system of claim 11 wherein the second abutment membercomprises a radially outward extending flange that abuts the interiorside of the stopper when the first abutment member is tightened aboutthe extending section.
 18. The fluid connector system of claim 11wherein the first abutment member comprises a plurality of radiallyoutward extending fins with which to grasp and rotate the first abutmentmember onto a threaded portion of the extending section to enableabutment of the first abutment member against the exterior side of thestopper.